SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/spl/StructureDefinition/SubmittedMedicinalPackaging | Version: 0.2.1 | |||
| Standards status: Trial-use | Maturity Level: 1 | Computable Name: SubmittedMedicinalPackaging | ||
Details around the packaging of submitted medicinal products.
Usage:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  PackagedProductDefinition |
PackagedProductDefinition | |||
  packageFor |
S | 1..1 | Reference(SubmittedMedicinalProduct) | The product that this is a pack for |
  marketingStatus |
S | 0..1 | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
 status |
S | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) |
 dateRange |
S | 1..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
 packaging |
S | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
  Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
  packageInstanceOf |
S | 0..1 | Reference(SubmittedMedicinalPackaging) | Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf |
| identifier |
S | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| type |
S | 1..1 | CodeableConcept | The physical type of the container of the items Binding: SPL Package Types (required) |
| quantity |
S | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| property |
S | 0..* | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following |
 coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP | |
 value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic Binding: SPL Combo Product Type (required) |
| containedItem |
S | 0..* | BackboneElement | The item(s) within the packaging |
| item |
S | 1..1 | CodeableReference(SubmittedManufacturedItem) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package |
| amount |
S | 1..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) |
| packaging |
S | 0..* | Allows containers (and parts of containers) within containers, still as a part of single packaged product | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.marketingStatus.status | required | SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatusesfrom this IG | |
| PackagedProductDefinition.packaging.type | required | SPLPackageTypeshttp://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypesfrom this IG | |
| PackagedProductDefinition.packaging.property.value[x] | required | SPLComboProductTypehttp://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductTypefrom this IG |
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
 modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| packageFor |
SΣ | 1..1 | Reference(SubmittedMedicinalProduct) | The product that this is a pack for |
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| marketingStatus |
SΣ | 0..1 | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status |
SΣ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) |
| dateRange |
SΣ | 1..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| packageInstanceOf |
S | 0..1 | Reference(SubmittedMedicinalPackaging) | Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier |
SΣ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: SPL Package Types (required) |
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| property |
SΣ | 0..* | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP | |
| value[x] |
SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: SPL Combo Product Type (required) |
| containedItem |
SΣ | 0..* | BackboneElement | The item(s) within the packaging |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item |
SΣ | 1..1 | CodeableReference(SubmittedManufacturedItem) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package |
| amount |
SΣ | 1..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) |
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.marketingStatus.status | required | SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatusesfrom this IG | |
| PackagedProductDefinition.packaging.type | required | SPLPackageTypeshttp://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypesfrom this IG | |
| PackagedProductDefinition.packaging.property.type | example | Pattern: SPLCMBPRDTPhttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.value[x] | required | SPLComboProductTypehttp://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductTypefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | ||||
| name |
Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc | ||||
| type |
Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package. | ||||
| packageFor |
SΣ | 1..1 | Reference(SubmittedMedicinalProduct) | The product that this is a pack for | ||||
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate |
Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
| containedItemQuantity |
Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) | ||||
| description |
Σ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product | ||||
| legalStatusOfSupply |
Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code |
Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| marketingStatus |
SΣ | 0..1 | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country |
Σ | 0..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified | ||||
| status |
SΣ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) | ||||
| dateRange |
SΣ | 1..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain | ||||
| restoreDate |
Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain | ||||
| copackagedIndicator |
Σ | 0..1 | boolean | Identifies if the drug product is supplied with another item such as a diluent or adjuvant | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) | ||||
| attachedDocument |
Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| packageInstanceOf |
S | 0..1 | Reference(SubmittedMedicinalPackaging) | Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf | ||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| identifier |
SΣ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: SPL Package Types (required) | ||||
| componentPart |
Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) | ||||
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material |
Σ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| alternateMaterial |
Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| shelfLifeStorage |
Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| property |
SΣ | 0..* | BackboneElement | General characteristics of this item | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP | |||||
| display |
0..1 | string | Representation defined by the system | |||||
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| value[x] |
SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: SPL Combo Product Type (required) | ||||
| containedItem |
SΣ | 0..* | BackboneElement | The item(s) within the packaging | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item |
SΣ | 1..1 | CodeableReference(SubmittedManufacturedItem) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | ||||
| amount |
SΣ | 1..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) | ||||
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product | ||||
| characteristic |
Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-typefrom the FHIR Standard | |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| PackagedProductDefinition.marketingStatus.status | required | SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatusesfrom this IG | |
| PackagedProductDefinition.packaging.type | required | SPLPackageTypeshttp://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypesfrom this IG | |
| PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.type | example | Pattern: SPLCMBPRDTPhttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.value[x] | required | SPLComboProductTypehttp://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductTypefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 3 elements(3 nested mandatory elements)
Must-Support: 16 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Maturity: 1
Differential View
This structure is derived from PackagedProductDefinition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition |
PackagedProductDefinition | |||
| packageFor |
S | 1..1 | Reference(SubmittedMedicinalProduct) | The product that this is a pack for |
| marketingStatus |
S | 0..1 | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| status |
S | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) |
| dateRange |
S | 1..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| packaging |
S | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| packageInstanceOf |
S | 0..1 | Reference(SubmittedMedicinalPackaging) | Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf |
| identifier |
S | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| type |
S | 1..1 | CodeableConcept | The physical type of the container of the items Binding: SPL Package Types (required) |
| quantity |
S | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| property |
S | 0..* | BackboneElement | General characteristics of this item |
| type |
S | 1..1 | CodeableConcept | A code expressing the type of characteristic Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP | |
| value[x] |
S | 1..1 | CodeableConcept | A value for the characteristic Binding: SPL Combo Product Type (required) |
| containedItem |
S | 0..* | BackboneElement | The item(s) within the packaging |
| item |
S | 1..1 | CodeableReference(SubmittedManufacturedItem) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package |
| amount |
S | 1..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) |
| packaging |
S | 0..* | Allows containers (and parts of containers) within containers, still as a part of single packaged product | |
| Documentation for this format | ||||
| Path | Conformance | ValueSet | URI |
| PackagedProductDefinition.marketingStatus.status | required | SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatusesfrom this IG | |
| PackagedProductDefinition.packaging.type | required | SPLPackageTypeshttp://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypesfrom this IG | |
| PackagedProductDefinition.packaging.property.value[x] | required | SPLComboProductTypehttp://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductTypefrom this IG |
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| contained |
0..* | Resource | Contained, inline Resources | |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored |
| packageFor |
SΣ | 1..1 | Reference(SubmittedMedicinalProduct) | The product that this is a pack for |
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. |
| marketingStatus |
SΣ | 0..1 | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| status |
SΣ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) |
| dateRange |
SΣ | 1..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain |
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap |
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |
| packageInstanceOf |
S | 0..1 | Reference(SubmittedMedicinalPackaging) | Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| identifier |
SΣ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier |
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: SPL Package Types (required) |
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) |
| property |
SΣ | 0..* | BackboneElement | General characteristics of this item |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following |
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP | |
| value[x] |
SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: SPL Combo Product Type (required) |
| containedItem |
SΣ | 0..* | BackboneElement | The item(s) within the packaging |
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized |
| item |
SΣ | 1..1 | CodeableReference(SubmittedManufacturedItem) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package |
| amount |
SΣ | 1..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) |
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.marketingStatus.status | required | SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatusesfrom this IG | |
| PackagedProductDefinition.packaging.type | required | SPLPackageTypeshttp://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypesfrom this IG | |
| PackagedProductDefinition.packaging.property.type | example | Pattern: SPLCMBPRDTPhttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.value[x] | required | SPLComboProductTypehttp://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductTypefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| PackagedProductDefinition |
0..* | PackagedProductDefinition | A medically related item or items, in a container or package | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: AllLanguages (required): IETF language tag for a human language
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | A unique identifier for this package as whole - not for the content of the package | ||||
| name |
Σ | 0..1 | string | A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc | ||||
| type |
Σ | 0..1 | CodeableConcept | A high level category e.g. medicinal product, raw material, shipping container etc Binding: PackageType (example): A high level categorisation of a package. | ||||
| packageFor |
SΣ | 1..1 | Reference(SubmittedMedicinalProduct) | The product that this is a pack for | ||||
| status |
?!Σ | 0..1 | CodeableConcept | The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status Binding: PublicationStatus (preferred): The lifecycle status of an artifact. | ||||
| statusDate |
Σ | 0..1 | dateTime | The date at which the given status became applicable | ||||
| containedItemQuantity |
Σ | 0..* | Quantity | A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (especially the long definition) | ||||
| description |
Σ | 0..1 | markdown | Textual description. Note that this is not the name of the package or product | ||||
| legalStatusOfSupply |
Σ | 0..* | BackboneElement | The legal status of supply of the packaged item as classified by the regulator | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| code |
Σ | 0..1 | CodeableConcept | The actual status of supply. In what situation this package type may be supplied for use Binding: LegalStatusOfSupply (example): The prescription supply types appropriate to a medicinal product | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | The place where the legal status of supply applies Binding: JurisdictionValueSet (example): Jurisdiction codes | ||||
| marketingStatus |
SΣ | 0..1 | MarketingStatus | Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated | ||||
| id |
0..1 | id | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| country |
Σ | 0..1 | CodeableConcept | The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements | ||||
| jurisdiction |
Σ | 0..1 | CodeableConcept | Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified | ||||
| status |
SΣ | 1..1 | CodeableConcept | This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: SPL Marketing Statuses ValueSet (required) | ||||
| dateRange |
SΣ | 1..1 | Period | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain | ||||
| restoreDate |
Σ | 0..1 | dateTime | The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain | ||||
| copackagedIndicator |
Σ | 0..1 | boolean | Identifies if the drug product is supplied with another item such as a diluent or adjuvant | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this package type (multiple means these are all possible manufacturers) | ||||
| attachedDocument |
Σ | 0..* | Reference(DocumentReference) | Additional information or supporting documentation about the packaged product | ||||
| packaging |
SΣ | 1..1 | BackboneElement | A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| Slices for extension |
0..* | Extension | Extension Slice: Unordered, Open by value:url | |||||
| packageInstanceOf |
S | 0..1 | Reference(SubmittedMedicinalPackaging) | Packaged Product Reference URL: http://hl7.org/fhir/us/spl/StructureDefinition/packageInstanceOf | ||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| identifier |
SΣ | 0..* | Identifier | An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier | ||||
| type |
SΣ | 1..1 | CodeableConcept | The physical type of the container of the items Binding: SPL Package Types (required) | ||||
| componentPart |
Σ | 0..1 | boolean | Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial) | ||||
| quantity |
SΣ | 0..1 | integer | The quantity of this level of packaging in the package that contains it (with the outermost level being 1) | ||||
| material |
Σ | 0..* | CodeableConcept | Material type of the package item Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| alternateMaterial |
Σ | 0..* | CodeableConcept | A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material Binding: PackageMaterial (example): A material used in the construction of packages and their components. | ||||
| shelfLifeStorage |
Σ | 0..* | ProductShelfLife | Shelf Life and storage information | ||||
| manufacturer |
Σ | 0..* | Reference(Organization) | Manufacturer of this packaging item (multiple means these are all potential manufacturers) | ||||
| property |
SΣ | 0..* | BackboneElement | General characteristics of this item | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| type |
SΣ | 1..1 | CodeableConcept | A code expressing the type of characteristic Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set. Required Pattern: At least the following | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| coding |
1..* | Coding | Code defined by a terminology system Fixed Value: (complex) | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| system |
1..1 | uri | Identity of the terminology system Fixed Value: http://hl7.org/fhir/us/spl/CodeSystem/codesystem-characteristicTypes | |||||
| version |
0..1 | string | Version of the system - if relevant | |||||
| code |
1..1 | code | Symbol in syntax defined by the system Fixed Value: SPLCMBPRDTP | |||||
| display |
0..1 | string | Representation defined by the system | |||||
| userSelected |
0..1 | boolean | If this coding was chosen directly by the user | |||||
| text |
0..1 | string | Plain text representation of the concept | |||||
| value[x] |
SΣ | 1..1 | CodeableConcept | A value for the characteristic Binding: SPL Combo Product Type (required) | ||||
| containedItem |
SΣ | 0..* | BackboneElement | The item(s) within the packaging | ||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| item |
SΣ | 1..1 | CodeableReference(SubmittedManufacturedItem) | The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package | ||||
| amount |
SΣ | 1..1 | Quantity | The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition) | ||||
| packaging |
SΣ | 0..* | See packaging (PackagedProductDefinition) | Allows containers (and parts of containers) within containers, still as a part of single packaged product | ||||
| characteristic |
Σ | 0..* | See property (PackagedProductDefinition) | Allows the key features to be recorded, such as "hospital pack", "nurse prescribable" | ||||
| Documentation for this format | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| PackagedProductDefinition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| PackagedProductDefinition.type | example | PackageTypehttp://hl7.org/fhir/ValueSet/package-typefrom the FHIR Standard | |
| PackagedProductDefinition.status | preferred | PublicationStatushttp://hl7.org/fhir/ValueSet/publication-statusfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.code | example | LegalStatusOfSupplyhttp://hl7.org/fhir/ValueSet/legal-status-of-supplyfrom the FHIR Standard | |
| PackagedProductDefinition.legalStatusOfSupply.jurisdiction | example | JurisdictionValueSethttp://hl7.org/fhir/ValueSet/jurisdictionfrom the FHIR Standard | |
| PackagedProductDefinition.marketingStatus.status | required | SPLMarketingStatuses (a valid code from SPL Marketing Statuses CodeSystem)http://hl7.org/fhir/us/spl/ValueSet/valueset-splMarketingStatusesfrom this IG | |
| PackagedProductDefinition.packaging.type | required | SPLPackageTypeshttp://hl7.org/fhir/us/spl/ValueSet/valueset-splPackageTypesfrom this IG | |
| PackagedProductDefinition.packaging.material | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.alternateMaterial | example | PackageMaterialhttp://hl7.org/fhir/ValueSet/package-materialfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.type | example | Pattern: SPLCMBPRDTPhttp://hl7.org/fhir/ValueSet/product-characteristic-codesfrom the FHIR Standard | |
| PackagedProductDefinition.packaging.property.value[x] | required | SPLComboProductTypehttp://hl7.org/fhir/us/spl/ValueSet/valueset-splComboProductTypefrom this IG |
| Id | Grade | Path(s) | Details | Requirements |
| dom-2 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() | |
| dom-3 | error | PackagedProductDefinition | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource : contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty() | |
| dom-4 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated : contained.meta.versionId.empty() and contained.meta.lastUpdated.empty() | |
| dom-5 | error | PackagedProductDefinition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() | |
| dom-6 | best practice | PackagedProductDefinition | A resource should have narrative for robust management : text.`div`.exists() | |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
This structure is derived from PackagedProductDefinition
Summary
Mandatory: 3 elements(3 nested mandatory elements)
Must-Support: 16 elements
Structures
This structure refers to these other structures:
Extensions
This structure refers to these extensions:
Maturity: 1
Other representations of profile: CSV, Excel, Schematron
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.1 based on FHIR 5.0.0. Generated 2024-10-26
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